MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ TAXO¿ A DISCS FOR DIFFERENTIATION OF GROUP A STREPTOCOCCI; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Model Number 231042

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

It was reported that one bd bbl¿ taxo¿ a discs for differentiation of group a streptococci was contaminated.There was no patient impact.The following information was provided by the initial reporter: contamination noticed after inoculation.No patient samples affected - "we were doing proficiency testing and an a/b plate." customer is not qualified to identify the contamination.Colony color is white.

Manufacturer Narrative

H3: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6.Investigation summary: a complaint investigation due to contamination with taxo a catalog 231042 batch no.: 2003421 was performed on retention samples.Returned goods were not received from customer.The investigation required to test product for performance, contamination, visual inspection, and batch record review.Retention samples performed as expected.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.Photos received from customer were evaluated.On 2 out of 3 photos containing an inoculated plate, it is observed an isolated colony in the inhibition area near the a taxo disc but not touching it.On the containing plate inoculated with "sample" it is observed a spread colonies (marked) near the disc, and one of the border is touching it.Based on photo evaluation the colonies near or at the border of the disc cannot be confirmed as disc contamination.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaint is not confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

Event Description

It was reported that one bd bbl¿ taxo¿ a discs for differentiation of group a streptococci was contaminated.There was no patient impact.The following information was provided by the initial reporter: contamination noticed after inoculation no patient samples affected - "we were doing proficiency testing and an a/b plate." customer is not qualified to identify the contamination colony color is white.

• Brand Name: BD BBL¿ TAXO¿ A DISCS FOR DIFFERENTIATION OF GROUP A STREPTOCOCCI
• Type of Device: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17152836
• MDR Text Key: 317824024
• Report Number: 2647876-2023-00040
• Device Sequence Number: 1
• Product Code: JTO
• UDI-Device Identifier: 00382902310426
• UDI-Public: 00382902310426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: 231042
• Device Catalogue Number: 231042
• Device Lot Number: 2003421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1